Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment-HORIZON-JU-IHI-2023-04-01-two-stage

The overall objective of this topic is to characterise the minipig for use in R&D of new therapeutics and innovative medical technologies. The knowledge generated in this proposal may facilitate innovative health solutions and improve disease understanding and human predictions. The goal is to advance biomedical R&D by generating background scientific data to evaluate if the minipigs could be a viable and feasible alternative to NHPs in key therapeutic areas, with a special focus on translatability from minipigs to humans.

ExpectedOutcome:
•IObtain and share biological knowledge of minipigs, thereby facilitating the development of innovative solutions by improving the translational understanding between minipigs versus NHPs and humans, including further understanding of the minipig immune system, with the overall aim to replace, reduce and refine the use of animals in non-clinical safety assessment.
•IA regulatory pathway for nonclinical safety assessment of biologicals and other new therapeutic modalities in minipigs with the potential to impact regulatory strategies.
•IPublicly available databases and software for physiological, genomic, transcriptomic, metabolomic, proteomic and epigenetic minipig data to understand underlying mechanisms of disease/toxicities and find new mode of actions for pharmaceutical interventions.
•ICharacterised and validated genetically modified minipig models:
     -genetically modified minipig models based on the CRISPR/Cas9 gene-editing technology.
     -minipigs with ‘humanised’ immune system components and effectors for testing biologicals.
     -small–sized micropig for efficacy/safety assessment to facilitate compound availability in pharmaceutical R&D.
•IAssessment of the utility of the minipig as a relevant toxicology species for immuno-safety testing using therapeutics which have been tested preclinically and clinically. Assisting and synergising the already existing translational and regulatory efforts related to immunological safety evaluation. Developing validated antibodies and in vitro immunoassays to characterise the immune system and assess the immuno-safety of therapeutics in minipigs.
•IMinipig-specific technology for automated study data: validated medical devices, biosensors, algorithms, software, and digital animal housing. Machine learning and artificial intelligence (AI)-based tools to monitor abnormalities in behaviour and physiological systems in undisturbed animals.

To ensure long-term sustainability, all the interdisciplinary science-based knowledge obtained and generated in the project arising from this topic will be shared, integrated, digitalised, and published in peer-reviewed journals, encouraging industry and academia to develop innovative medical science solutions and technologies, such as scientifically and ethically sound animal models, assays, biomarkers, monitoring devices, biosensors for normal physiological behaviour, and algorithms. Based on the close collaboration with regulatory bodies, the knowledge generated in the project is further expected to impact regulatory guideline strategies. All outputs will require long-term sustainability and maintenance to fulfil the scope of the project.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System

at stage 1 of a two-stage Call, the limit for RIA short proposals is 20 pages;
at stage 2 of a two-stage Call, the limit for RIA full proposals is 50 pages.

Documents: (Check them on the webside).

 IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
 IHI JU Proposal template (RIA/SP) - Part B

•Colombia is eligible as a third country, for this it must participate with the role of partner together with a consortium with at least three entities from different European/associated countries).